BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM 3 EZ 3.0 X 15MM

    MDR report key: 3246954 · Received July 25, 2013

    Report

    Report Number
    3008853977-2013-00259
    Event Type
    Death
    Date Received
    July 25, 2013
    Date of Event
    June 29, 2013
    Report Date
    July 10, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. HOWEVER, PATIENT OUTCOME OF DEATH IS A KNOWN RISK ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND IS NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    BRAND NAME AND CATALOG # POPULATED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT APPROXIMATELY 3 DAYS POST PROCEDURE THE PATIENT DIED; THEREFORE, IT IS BELIEVED THAT THE APPROXIMATE DATE IS (B)(6) 2013. SUBJECT DEVICE WAS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENT PLACEMENT (UNKNOWN ANATOMICAL LOCATION) PROCEDURE AND WAS DISCHARGED HOME. IT WAS REPORTED THAT APPROXIMATELY 3 DAYS POST PROCEDURE THE FAMILY FOUND THE PATIENT DEAD. THERE WAS NO AUTOPSY PERFORMED; THEREFORE, THE CAUSE OF DEATH WAS NOT DETERMINED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENT PLACEMENT (UNKNOWN ANATOMICAL LOCATION) PROCEDURE AND WAS DISCHARGED HOME. IT WAS REPORTED THAT APPROXIMATELY 3 DAYS POST PROCEDURE THE FAMILY FOUND THE PATIENT DEAD. THERE WAS NO AUTOPSY PERFORMED; THEREFORE THE CAUSE OF DEATH WAS NOT DETERMINED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL STENT PLACEMENT (UNKNOWN ANATOMICAL LOCATION) PROCEDURE AND WAS DISCHARGED HOME. IT WAS REPORTED THAT APPROXIMATELY 3 DAYS POST PROCEDURE, THE FAMILY FOUND THE PATIENT DEAD. THERE WAS NO AUTOPSY PERFORMED; THEREFORE THE CAUSE OF DEATH WAS NOT DETERMINED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348219 NEUROFORM 3 EZ 3.0 X 15MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death